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Q&A

In your opinion, what is the greatest challenge in your field?

To attract more physicians in the area of pharmacovigilance. Although all healthcare professionals are involved in the detection of adverse reactions, I have seen fewer and fewer physicians interested in this specialty, whether in companies or in regulatory authorities. Some reasons for this situation: (i) University students are not well-instructed on the safety of drugs and any types of treatment in general. The focus is mainly on drug efficacy. (ii) During their practice healthcare professionals are more interested in how to administer treatments. (iii) Pharmacovigilance is negatively viewed as a failure of the medical practice, while it is part of the job of the prescribers to understand why the patient experienced adverse reactions and report to the right institutions in order to know more about them and take appropriate measures to reduce the risk.

Where do you see your field going? What is your vision of the field in 2030?

Knowledge of drug safety is growing due to new technologies involving the patients themselves, big data, real world investigations, and genetics. Treatments are more personalized in order to avoid or at least reduce the risk carried by new therapeutic strategies. But the main data is still in the field to be collected by healthcare professionals, something that should be done by physicians (see above) trained to identify relevant data. Pharmacoepidemiology methods are essential, but they should be based on robust data collected by trained people.

What advice would you give your younger self about to enter the “real world?”

To be passionate about what you are doing. To love sharing knowledge with lay people and your colleagues. To be sincere with yourself. To love searching for better ways to do your daily work.

Imagine a day without work, the internet, and any other obligations. What would you do?

Help people be happy and know more about them. Read books and maintain my knowledge.

What would you like to see DIA do for you in the future?

I am retired and do not expect much for me from DIA, but I would like to see more DIA training courses on the medical aspects of pharmacovigilance to educate healthcare professionals in this area. Maybe more collaboration with universities to introduce pharmacovigilance concepts early in the medical programs and attract more physicians, because this specialty is a great opportunity to exercise their medical knowledge. Too much importance is currently given to regulatory requirements without medical content, whether during drug development or in post-marketing.

BIOGRAPHY

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.